Ignite Creation Date:
2025-12-18 @ 9:30 AM
Ignite Modification Date:
2025-12-23 @ 11:16 PM
Study NCT ID:
NCT02591147
Status:
None
Last Update Posted:
2023-03-14 00:00:00
First Post:
2015-10-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Silver Diamine Fluoride Pilot Study (SDF)
Sponsor:
None
Organization:
Study Overview
Official Title:
Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study
Status:
None
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SDF
Brief Summary:
This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.
SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.
SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.
SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.
SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: